RecruitingNot ApplicableNCT06757296

Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

Sponsor

Singapore Health Services

Enrollment

500 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Bariatric Surgery Metabolic Syndrome Severe Obesity Reflux, Gastroesophageal

Summary

The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria4

Age: 21-65 years
Patients going for LSG at participating hospitals.
Able to provide informed consent
Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.

Exclusion Criteria10

Patients who were breast feeding or pregnant
Severe psychiatric illness
Eating disorder
Active neoplastic disease
End-stage renal disease
Patients with bleeding diathesis
Patients with pacemakers or implantable cardiac defibrillators
Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
Treatment with anti-platelet agents that could not be temporarily discontinued